Safety Study of Cosmetic Tissue Augmentation in People of Color
NCT ID: NCT01147172
Last Updated: 2017-10-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2009-03-31
2010-08-31
Brief Summary
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This study is designed to evaluate the safety of an injectable hyaluronic acid based dermal filler Elevess (Anika Therapeutics, Inc., Bedford, MA). Safety will be evaluated by incidence and severity of keloid formation and pigmentation changes, and other potential adverse events in people with Fitzpatrick skin types IV, V and VI who have elected to undergo nasolabial fold (NLF) treatment with Elevess.
1\. Fitzpatrick Classification of Skin Type as: IV - Burns minimally, always tans well (moderate/light brown skin; Mediterranean, Asian, Hispanic. V - Rarely burns, tans profusely (dark brown/brown skin: Middle eastern, Latin, light skinned Black, Indian) VI - Never burns, (deeply pigmented dark brown to black skin;Black)
Detailed Description
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Safety: Primary Safety Endpoint assessments will be: 1) keloid formation at the site of injection at 2, 6, 12 and 24 weeks, 2) pigmentation changes at the site of injection compared to adjacent skin at 2, 6, 12 and 24 weeks, and 3) overall adverse events. A subject diary will also be collected.
Effectiveness: No formal effectiveness evaluation will be performed.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Elevess
Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite
Elevess
Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
Interventions
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Elevess
Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
Eligibility Criteria
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Inclusion Criteria
* Bilateral nasolabial folds which, in the investigator's judgment, can be corrected with Elevess.
* Age greater or equal to 18 years.
Exclusion Criteria
* Subject has severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
* Subject has allergies to the components of Elevess: hyaluronic acid, lidocaine, sodium metabisulfite or gram positive bacterial proteins.
* Subject has a history of severe keloids and/or hypertrophic scars.
* Subject has ever received any soft tissue augmentation in any area of the face and subject is unwilling to forgo all other soft tissue augmentation for the duration of the study.
* Subject has received any aesthetic or dermatologic treatments or procedures in any area of the face in the previous 6 months and subject is unwilling to forgo such treatments or procedures for the duration of the study.
* Subject has active facial acne lesions, severe acne scarring or pigmentation disorders at the injection site that might affect clinical assessment of the nasolabial folds.
* Subject has ever received an injection or implant of silicone in any area of the face.
* Subject has received immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3 months.
* Subject has a history of a connective tissue disease.
* Subject is positive for HIV/AIDS or hepatitis C.
* Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of screening
18 Years
ALL
Yes
Sponsors
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Anika Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frederic Brandt, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Research Institute, LLC
William P Coleman, MD
Role: PRINCIPAL_INVESTIGATOR
Private Practice
Michael Gold, MD
Role: PRINCIPAL_INVESTIGATOR
Tennessee Clinical Research Center
Alicia Barba, MD
Role: PRINCIPAL_INVESTIGATOR
International Dermatology Research, Inc.
Andrew Alexis, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's-Roosevelt Hospital Center
Michael Jarratt, MD
Role: PRINCIPAL_INVESTIGATOR
Derm Research, Inc.
Pearl Grimes, MD
Role: PRINCIPAL_INVESTIGATOR
Vitiligo & Pigmentation Institute of Southern California
Marta Rendon, MD
Role: PRINCIPAL_INVESTIGATOR
Skin Care Research, Inc.
Eduardo Tschen, MD
Role: PRINCIPAL_INVESTIGATOR
Academic Dermatology Associates
Locations
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Vitiligo and Pigmentation Inst of Southern California
Los Angeles, California, United States
Skin Care Research, Inc.
Boca Raton, Florida, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
International Dermatology Research
Miami, Florida, United States
William Coleman, MD
Metairie, Louisiana, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
St Luke's Roosevelt
New York, New York, United States
Tenneesee Clinical Research Center
Nashville, Tennessee, United States
Derm Research, Inc.
Austin, Texas, United States
Countries
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References
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Kokelj F, Burnett JW. Treatment of a pigmented lesion induced by a Pelagia noctiluca sting. Cutis. 1990 Jul;46(1):62-4.
Linder SA, Mele JA 3rd, Harries T. Chronic hyperpigmentation from a heated mustard compress burn: a case report. J Burn Care Rehabil. 1996 Jul-Aug;17(4):351-2. doi: 10.1097/00004630-199607000-00012.
Royston SL, Wright PA, Widdowson DC, Wareham WJ, Strike PW. Adverse effects reported in epilatory ruby laser treatment. Lasers Med Sci. 2008 Jan;23(1):35-9. doi: 10.1007/s10103-007-0451-0. Epub 2007 Mar 13.
Tomita Y, Maeda K, Tagami H. Mechanisms for hyperpigmentation in postinflammatory pigmentation, urticaria pigmentosa and sunburn. Dermatologica. 1989;179 Suppl 1:49-53. doi: 10.1159/000248449.
Other Identifiers
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CTA0701
Identifier Type: -
Identifier Source: org_study_id